India ICEMR Severe <i>P. vivax</i> and <i>falciparum</i> Cohort

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Background: We undertook a prospective study to assess the burden of severe malaria in Ahmedabad, Gujarat, India. The study was carried out at the BJMC Civil Hospital, the largest hospital in Gujarat, to assess the morbidity of severe P. vivax malaria compared to the morbidity associated with severe P. falciparum malaria.

Objectives:

Document the clinical/laboratory parameters, outcomes, and management of severe malaria in the selected facility
Compare the clinical/laboratory parameters, outcomes, and management of severe vivax malaria with that of severe falciparum malaria, and evaluate potential markers of severity

Methodology:

Geographic Location/Study Sites: Gujarat, India

Dates of Data Collection: December 2016-November 2017

Study Design: Longitudinal cohort of people with Plasmodium infection

Data Collection: This prospective, hospital-based study focused on patients admitted with severe P. falciparum, P. vivax or co-infections with both species. Microscopy-diagnosed infections with or without WHO-defined severe malaria symptoms, as well as one case of suspected malaria but with negative microscopy results were enrolled after informed consent forms were obtained from patients or their legal representatives. All case record forms (CRFs) were anonymized, digitized and stored using the REDCap (Research Electronic Data Capture) system, which allowed subsequent extraction of datasets.

Study Documentation:

Data dictionary

ClinEpiDB Data Integration: Data files were provided to ClinEpiDB as flat csv files. Redundant or administrative columns were dropped from presentation on ClinEpiDB.org. All dates were obfuscated per participant through the application of a random number algorithm that shifted dates no more than seven days to comply with the ethical conduct of human subjects research.

Acknowledgements: We thank the staff of the Ahmedabad Civil hospital, as well as Drs Lalitha Ramanathapuram and Annie Kessler for their logistical support. We also thank Dr. Neena Valecha, the former Director of ICMR-NIMR for facilitating the study, and the staff of the NIMR Field Unit Nadiad for their participation.

Financial Support: Research reported in this publication was supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under Award Number U19AI089676 as part of the International Centers for Excellence in Malaria Research.

Ethics Statement: Institutional Review Board approval was obtained from New York University, and Institutional Ethical Clearance from NIMR. Informed consent was obtained from all subjects or, if subjects were under 18, from a parent and/or legal guardian.

Last updated: January 5, 2022A hospital-based cohort study was conducted to compare severe malaria morbidity due to Plasmodium falciparum and Plasmodium vivax. Patients admitted to the hospital with severe malaria were enrolled and followed until discharge.